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Apellis Pharmaceuticals, Inc. recalls Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of
Recalled October 11, 2023 · FDA recall Z-2653-2023 · Apellis Pharmaceuticals
Hazard
19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis · FDA Class II
Units
61,943 units
Sold at
US Nationwide distribution.
Description
19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis
Product
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G
Manufacturer(s)
Apellis Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →